Rabies PreventionPhase 3NCT07500207
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
A Phase 3 study testing Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell) and approved Rabies vaccine in people with Rabies Prevention, run by Changchun BCHT Biotechnology Co. at 1 site in China.
Trial summary
Neutralizing antibody seroconversion rate and geometric mean concentration in seronegative participants of each group at 14 days after the first dose of immunization. The seroconversion rate of neutralizing antibodies 42 days after the first dose among seronegative participants before vaccination in each group Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Prevention
- What is being tested?
- Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell) and approved Rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2026to 25 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants aged 10 to 60 years old;
- Able to obtain informed consent from the participants themselves and/or their guardians;
- The participants themselves and/or their guardians are able to comply with the requirements of the clinical trial protocol.
Who cannot join
- Axillary temperature >37.0°C on the day of vaccination;
- History of rabies vaccination or administration of rabies virus passive immunization preparations;
- History of bites or scratches (with broken skin) by dogs or other mammals within 1 year before the first vaccination;
- Suffering from an acute illness or acute exacerbation of a chronic disease within 3 days before the first vaccination;
- Positive urine pregnancy test result or lactation in female participants of childbearing age, or pregnancy planning for female participants of childbearing age, male participants and their female sexual partners from the start of the trial until 6 months after the completion of the full vaccination course;
- History of severe allergies requiring medical intervention or severe adverse reactions to vaccines (such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrotizing reaction (Arthus reaction), angioedema, etc.), or allergy to any component of the investigational vaccine, such as human albumin, dextran 40, sucrose, glycine, disodium hydrogen phosphate, potassium dihydrogen phosphate;
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- Known or suspected malignant tumor, autoimmune disease, immunodeficiency or immunosuppression (e.g., human immunodeficiency virus (HIV) infection, organ transplantation, systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.);
- Use of immunosuppressive agents and/or immunomodulators (e.g., systemic glucocorticoids, targeted immunomodulators used continuously for more than 14 days), cytotoxic therapy, etc., within 6 months before the first vaccination or planned long-term use thereof;
- Congenital malformations or developmental disorders affecting organ function, hypertension not effectively controlled by medication (only for those aged 18-60 years) [systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite maintenance medication], severe liver and kidney diseases (severe cases, e.g., complicated with diabetes), etc.;
- Contraindications to intramuscular injection, such as local infection or skin lesions at the injection site, severe thrombocytopenia, abnormal coagulation function or history of coagulation disorders;
- History or family history of mental and neurological diseases such as convulsions, epilepsy, encephalopathy and psychosis;
- Received blood products or immunoglobulin products within the past 3 months or planned to use them during the trial;
- Received other investigational medicinal products within 1 month before administration of the investigational vaccine or are currently participating in other clinical trials;
- Received live attenuated vaccines within 14 days before enrollment, or subunit or inactivated vaccines within 7 days before enrollment;
- Other conditions that the investigator considers may affect the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Human Rabies Vaccine (Human Diploid Cell) Administered Via Different Immunization Schedules Using a Randomized, Blinded, Positive-Controlled Design
Neutralizing antibody seroconversion rate and geometric mean concentration in seronegative participants of each group at 14 days after the first dose of immunization.
The seroconversion rate of neutralizing antibodies 42 days after the first dose among seronegative participants before vaccination in each group
- Conditions
- Rabies Prevention
- Being tested
- Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell), approved Rabies vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell)Biological
Dosage schedule:
Five-dose regimen: one dose on days 0, 3, 7, 14, and 28 respectively; 2-1-1 regimen: administration on days 0, 7, and 21, with 2 doses on day 0 and 1 dose on each of the other days; Simplified four-dose regimen: one dose on days 0, 3, 7, and 14, or one dose on days 0, 3, 7, and 28 respectively.
approved Rabies vaccineBiological
One dose shall be administered on days 0, 3, 7, 14, and 28 respectively.
| Study group | Role | What they receive |
|---|---|---|
| BCHT rabies vaccine | Experimental | Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell) Receives: Biological: Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell) |
| Approved rabies vaccine | Active comparator | Approved Lyophilized Human Rabies Vaccine (Human Diploid Cell) Receives: Biological: approved Rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutralizing antibodies after the first dose
Seroconversion rate and geometric mean concentration of neutralizing antibodies
Measured: 14 days and 42 day after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start4 Mar 2026
- Primary completion25 May 2026 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies PreventionStudies of the same condition, open and under way.
- More trials run by Changchun BCHT Biotechnology Co.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun BCHT Biotechnology Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500207
- Sponsor's protocol ID
- B1901-F20230313-2
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Human Rabies Vaccine (Human Diploid Cell) Administered Via Different Immunization Schedules Using a Randomized, Blinded, Positive-Controlled Design
- ClinicalTrials.gov ID
- NCT07500207
- Acronym / sponsor ID
- B1901-F20230313-2
- Conditions
- Rabies Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Changchun BCHT Biotechnology Co.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neutralizing antibody seroconversion rate and geometric mean concentration in seronegative participants of each group at 14 days after the first dose of immunization.
The seroconversion rate of neutralizing antibodies 42 days after the first dose among seronegative participants before vaccination in each group
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCHT rabies vaccine | Experimental | Biological: Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell)Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell) |
| Approved rabies vaccine | Active comparator | Biological: approved Rabies vaccineApproved Lyophilized Human Rabies Vaccine (Human Diploid Cell) |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participants aged 10 to 60 years old;
- Able to obtain informed consent from the participants themselves and/or their guardians;
- The participants themselves and/or their guardians are able to comply with the requirements of the clinical trial protocol.
Key exclusion criteria (15 listed)
- Axillary temperature >37.0°C on the day of vaccination;
- History of rabies vaccination or administration of rabies virus passive immunization preparations;
- History of bites or scratches (with broken skin) by dogs or other mammals within 1 year before the first vaccination;
- Suffering from an acute illness or acute exacerbation of a chronic disease within 3 days before the first vaccination;
- Positive urine pregnancy test result or lactation in female participants of childbearing age, or pregnancy planning for female participants of childbearing age, male participants and their female sexual partners from the start of the trial until 6 months after the completion of the full vaccination course;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell)Dosage schedule: Five-dose regimen: one dose on days 0, 3, 7, 14, and 28 respectively; 2-1-1 regimen: administration on days 0, 7, and 21, with 2 doses on day 0 and 1 dose on each of the other days; Simplified four-dose regimen: one dose on days 0, 3, 7, and 14, or one dose on days 0, 3, 7, and 28 respectively. | Biological | BCHT rabies vaccine |
| approved Rabies vaccineOne dose shall be administered on days 0, 3, 7, 14, and 28 respectively. | Biological | Approved rabies vaccine |
Primary outcome
neutralizing antibodies after the first dose
Time frame: 14 days and 42 day after the first dose
Seroconversion rate and geometric mean concentration of neutralizing antibodies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell) and approved Rabies vaccine in people with Rabies Prevention, run by Changchun BCHT Biotechnology Co. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neutralizing antibodies after the first dose (time frame: 14 days and 42 day after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.